ST Segment Elevation Myocardial Infarction (STEMI)NCT06794801

Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study

A study testing Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB） and Conventional Drug coated balloon (DCB) in people with ST Segment Elevation Myocardial Infarction (STEMI), run by LanZhou University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Trial Goals: 1. Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation Myocardial Infarction (STEMI). 2. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: ST Segment Elevation Myocardial Infarction (STEMI)
What is being tested?: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB） and Conventional Drug coated balloon (DCB)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteChina
Study dates: Jan 2025to Dec 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute ST-Elevation Myocardial Infarction Meeting PPCI Criteria: 1) Chest pain lasting more than 20 minutes, with ST-segment elevation of at least 1 mm in two or more adjacent leads, new left bundle branch block, or evidence of posterior wall myocardial infarction; 2) Onset of symptoms within 12 hours.
Patients Who Have Received Thrombolytic Therapy Within 6 Hours of Symptom Onset and Are Eligible for Rescue PCI Within 24 Hours;
Infarct-Related Artery Selection Imaging and Pre-Treatment Criteria Meeting PPCI Standards: 1) De novo lesions. 2) Reference vessel diameter between 2.5 mm and 4 mm. 3) Successful pre-treatment of target lesions: post-pre-treatment residual stenosis of the culprit vessel ≤ 30%, with no type C dissections (or intravascular imaging indicating significant residual plaque burden at the site of dissection, with transverse expansion > 60°, longitudinal expansion > 2 mm, dissection involving the media or adventitia, and located at the distal end of the stent), no hematoma, and no significant thrombus (TIMI thrombus burden grade ≤ 2);
Sufficient compliance with the study protocol, agreement to undertake follow-up, and coronary angiography at 9 months;
Voluntary Participation in This Study, Including Signing a Written Informed Consent with Understanding of All Risks and Benefits Described in the Informed Consent Document.

Who cannot join

Age < 18 years and > 75 years;
History of prior myocardial infarction;
Allergy to contrast agent/inability to tolerate contrast;
Known contraindications / inability to tolerate bivalirudin, fondaparinux, heparin, aspirin, clopidogrel, and/or ticagrelor;
Complex coronary lesions: left main lesions, lesions at the ostia of the left anterior descending or circumflex arteries, lesion length > 30 mm, severe calcification, severe tortuosity or angulation, bifurcation lesions requiring the implantation of more than two drug-coated balloons (DCBs) or drug-eluting stents;
In-stent restenosis or in-stent thrombus lesions;

Show all 17Show fewer

Planned simultaneous intervention on non-target lesions;
Active bleeding or recent history of bleeding;
Uncertain neurological outcomes, such as resuscitation;
Intubation / ventilation;
Cardiogenic shock prior to randomization;
Known intracranial disease (tumors, aneurysms, arteriovenous malformations, hemorrhagic CVA, ischemic CVA/TIA within the last 6 months, including permanent neurological deficits from ischemic cerebrovascular disease) ;
Refusal of blood transfusion;
Planned major surgery within 6 weeks;
Stent implantation < 1 month prior to enrollment;
Life expectancy of less than 12 months;
Participation in another clinical trial that interferes with this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Zhao, Dr contact

Yurun Su, Dr contact

China1 site

LanZhou University
Lanzhou, Gansu, 730000
Jing Zhao, Dr, +8618919062327, jzhao14@fudan.edu.cn
Yurun Su, +8615682845605, 15682845605@163.com

Other trials in China

About this study

Official title: An Open-Label, Prospective, Single-Center, Randomized Controlled Trial Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study

Trial Goals:

Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation Myocardial Infarction (STEMI).
Evaluation of Hybrid IVUS-OCT System for Intraoperative Evaluation of DCAB or Conventional DCB Treatment Safety and Effectiveness for De Novo Lesions During Emergency Percutaneous Coronary Intervention (PCI) in Patients with STEMI.

The primary outcome is late lumen loss (LLL) assessed at 9 months following emergency PCI, measured using quantitative coronary angiography (QCA).

Conditions: ST Segment Elevation Myocardial Infarction (STEMI)
Being tested: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）, Conventional Drug coated balloon (DCB)
Keywords: Drug Coated Autoperfusion Balloon Dilatation Catheter, Percutaneous Coronary Intervention, VUS-OCT Multimodal Imaging, De novo lesion
Medical subject headings: ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）Device
In the experimental arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successfully prepared lesions will be treated with a drug-coated autoperfusion balloon dilatation catheter (DCAB). Successful lesion preparation is defined as post-pretreatment residual stenosis ≤ 30%, no type C dissections, intravascular imaging confirming no significant residual plaque burden at the dissection site, no transverse expansion > 60°, no longitudinal expansion > 2 mm, no dissection involving the media or adventitia, and no location at the stent distal end. There should be no hematoma and no significant thrombus (TIMI thrombus burden grade ≤ 2). If the angiographic and intravascular imaging results after DCAB treatment are unsatisfactory, an emergency drug-eluting stent (DES) will be implanted.
Conventional Drug coated balloon (DCB)Device
Also called Bingo® PTCA Drug Delivery System
In the control arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successful lesion preparation (residual stenosis ≤ 30%, no type C dissections, no significant residual plaque burden, no dissection involving the media or adventitia, no transverse expansion > 60°, no longitudinal expansion > 2 mm, no location at the stent distal end, no hematoma, TIMI thrombus burden grade ≤ 2) will be treated with a conventional DCB coated with 3 μg/mm2 paclitaxel. If angiographic and intravascular imaging results are unsatisfactory, a bailout DES will be implanted.

Study groups in NCT06794801
Study group	Role	What they receive
Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）	Experimental	3 μg/mm² paclitaxel-coated drug-coated autoperfusion balloon dilatation catheter (DCAB). The DCAB features two radiopaque marker rings at the balloon shoulders for intravascular imaging and positioning, self-perfusion holes on the catheter shaft, and an additional radiopaque marker ring proximal to the perfusion holes to indicate their location. The catheter shaft is hydrophilically coated to facilitate blood flow through the perfusion holes when the guidewire is retracted. Preclinical studies show this design allows 15%-20% of arterial blood to reach the distal coronary artery. Receives: Device: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）
Conventional Drug coated ballon（DCB）	Active comparator	Bingo® PTCA Drug Delivery System: drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2. Receives: Device: Conventional Drug coated balloon (DCB)

What is being measured

The primary outcome is the main question the study is designed to answer.

Late lumen loss at 9 months after index PCI
Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention.
Measured: 9±2 months

Secondary outcomes (6)

Incidence of patient-oriented composite endpoint (PoCE)
Incidence of patient-oriented composite endpoint (PoCE) and individual components of PoCE: defined as a composite of all-cause death, Target vessel failure, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.
Measured: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications
Bleeding Academic Research Consortium type 3 and 5 bleeding complications
Measured: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation
Based on the results of coronary angiography after DCB implantation
Measured: index PCI
The incidence of bailout stenting following DCB implantation
The following criteria are used to define it: TIMI flow ≤ Grade 2; residual stenosis > 30%; Type C (or intravascular imaging demonstrating significant residual plaque burden at the dissection site, lateral extension > 60°, longitudinal extension > 2 mm, dissection involving the media or adventitia); and higher dissection.
Measured: index PCI
Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.
Change in minimum lumen area and lumen area loss (in mm2), as assessed by IVUS-OCT multimodal imaging, compared with pre-procedure baseline following coronary artery drug-coated balloon angioplasty.
Measured: index PCI
Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation.
Incidence of intolerable worsening chest pain, hemodynamic instability, ST-segment changes, and severe arrhythmias during DCB expansion and duration of DCB expansion.
Measured: index PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2025Dec 2030

First posted27 Jan 2025
Study startJan 2025 (estimated)
Primary completionDec 2026 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for ST Segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 134 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06794801
Sponsor's protocol ID: LLYY2024PJ171
Status last verified: Jan 2025
First submitted: 16 Jan 2025
Last updated: 27 Jan 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data is available and can be requested, subject to approval, if a reasonable clinical research analysis plan is provided to the corresponding author.

Publications

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
PubMed 12517460
Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.
PubMed 10607811
Suryapranata H, van 't Hof AW, Hoorntje JC, de Boer MJ, Zijlstra F. Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction. Circulation. 1998 Jun 30;97(25):2502-5. doi: 10.1161/01.cir.97.25.2502.
PubMed 9657469
Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 Aug 13;106(7):798-803. doi: 10.1161/01.cir.0000025585.63486.59.
PubMed 12176950
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
PubMed 15500897
Brott BC, Anayiotos AS, Chapman GD, Anderson PG, Hillegass WB. Severe, diffuse coronary artery spasm after drug-eluting stent placement. J Invasive Cardiol. 2006 Dec;18(12):584-92.
PubMed 17197707
Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.
PubMed 18725485
Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.
PubMed 21251625
Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.
PubMed 19463469
Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
PubMed 30898253
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.
PubMed 33091360
Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
PubMed 32473887
Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman JP, Kiemeneij F, Patterson MS, Slagboom T, van der Schaaf RJ. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014 Sep;10(5):584-90. doi: 10.4244/EIJV10I5A101.
PubMed 25256200
Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.
PubMed 16971717
Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvanne M, Suttorp MJ, Violini R, Schomig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.
PubMed 17901079

Interested in taking part?

Jing Zhao, Dr

+8618919062327

jzhao14@fudan.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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ST Elevation Myocardial Infarction

All ST Segment Elevation Myocardial Infarction (STEMI) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Prospective, Single-Center, Randomized Controlled Trial Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study
ClinicalTrials.gov ID: NCT06794801
Acronym / sponsor ID: LLYY2024PJ171
Conditions: ST Segment Elevation Myocardial Infarction (STEMI)
Keywords: Drug Coated Autoperfusion Balloon Dilatation Catheter, Percutaneous Coronary Intervention, VUS-OCT Multimodal Imaging, De novo lesion
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 134 participants (estimated)
Lead sponsor: LanZhou UniversityUniversity, hospital or other
Study start: Jan 2025 (estimated)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2030 (estimated)
First posted: 27 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Trial Goals:

Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation Myocardial Infarction (STEMI).
Evaluation of Hybrid IVUS-OCT System for Intraoperative Evaluation of DCAB or Conventional DCB Treatment Safety and Effectiveness for De Novo Lesions During Emergency Percutaneous Coronary Intervention (PCI) in Patients with STEMI.

The primary outcome is late lumen loss (LLL) assessed at 9 months following emergency PCI, measured using quantitative coronary angiography (QCA).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）	Experimental	Device: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）3 μg/mm² paclitaxel-coated drug-coated autoperfusion balloon dilatation catheter (DCAB). The DCAB features two radiopaque marker rings at the balloon shoulders for intravascular imaging and positioning, self-perfusion holes on the catheter shaft, and an additional radiopaque marker ring proximal to the perfusion holes to indicate their location. The catheter shaft is hydrophilically coated to facilitate blood flow through the perfusion holes when the guidewire is retracted. Preclinical studies show this design allows 15%-20% of arterial blood to reach the distal coronary artery.
Conventional Drug coated ballon（DCB）	Active comparator	Device: Conventional Drug coated balloon (DCB)Bingo® PTCA Drug Delivery System: drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Acute ST-Elevation Myocardial Infarction Meeting PPCI Criteria: 1) Chest pain lasting more than 20 minutes, with ST-segment elevation of at least 1 mm in two or more adjacent leads, new left bundle branch block, or evidence of posterior wall myocardial infarction; 2) Onset of symptoms within 12 hours.
Patients Who Have Received Thrombolytic Therapy Within 6 Hours of Symptom Onset and Are Eligible for Rescue PCI Within 24 Hours;
Infarct-Related Artery Selection Imaging and Pre-Treatment Criteria Meeting PPCI Standards: 1) De novo lesions. 2) Reference vessel diameter between 2.5 mm and 4 mm. 3) Successful pre-treatment of target lesions: post-pre-treatment residual stenosis of the culprit vessel ≤ 30%, with no type C dissections (or intravascular imaging indicating significant residual plaque burden at the site of dissection, with transverse expansion > 60°, longitudinal expansion > 2 mm, dissection involving the media or adventitia, and located at the distal end of the stent), no hematoma, and no significant thrombus (TIMI thrombus burden grade ≤ 2);
Sufficient compliance with the study protocol, agreement to undertake follow-up, and coronary angiography at 9 months;
Voluntary Participation in This Study, Including Signing a Written Informed Consent with Understanding of All Risks and Benefits Described in the Informed Consent Document.

Key exclusion criteria (17 listed)

Age < 18 years and > 75 years;
History of prior myocardial infarction;
Allergy to contrast agent/inability to tolerate contrast;
Known contraindications / inability to tolerate bivalirudin, fondaparinux, heparin, aspirin, clopidogrel, and/or ticagrelor;
Complex coronary lesions: left main lesions, lesions at the ostia of the left anterior descending or circumflex arteries, lesion length > 30 mm, severe calcification, severe tortuosity or angulation, bifurcation lesions requiring the implantation of more than two drug-coated balloons (DCBs) or drug-eluting stents;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）In the experimental arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successfully prepared lesions will be treated with a drug-coated autoperfusion balloon dilatation catheter (DCAB). Successful lesion preparation is defined as post-pretreatment residual stenosis ≤ 30%, no type C dissections, intravascular imaging confirming no significant residual plaque burden at the dissection site, no transverse expansion > 60°, no longitudinal expansion > 2 mm, no dissection involving the media or adventitia, and no location at the stent distal end. There should be no hematoma and no significant thrombus (TIMI thrombus burden grade ≤ 2). If the angiographic and intravascular imaging results after DCAB treatment are unsatisfactory, an emergency drug-eluting stent (DES) will be implanted.	Device	Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）
Conventional Drug coated balloon (DCB)Also: Bingo® PTCA Drug Delivery SystemIn the control arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successful lesion preparation (residual stenosis ≤ 30%, no type C dissections, no significant residual plaque burden, no dissection involving the media or adventitia, no transverse expansion > 60°, no longitudinal expansion > 2 mm, no location at the stent distal end, no hematoma, TIMI thrombus burden grade ≤ 2) will be treated with a conventional DCB coated with 3 μg/mm2 paclitaxel. If angiographic and intravascular imaging results are unsatisfactory, a bailout DES will be implanted.	Device	Conventional Drug coated ballon（DCB）

Primary outcome

Late lumen loss at 9 months after index PCI
Time frame: 9±2 months
Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention.

6 secondary outcomes

Incidence of patient-oriented composite endpoint (PoCE)
Time frame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications
Time frame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation
Time frame: index PCI
The incidence of bailout stenting following DCB implantation
Time frame: index PCI
Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.
Time frame: index PCI
Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation.
Time frame: index PCI

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Background: PubMed 12517460Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
Background: PubMed 10607811Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.
Background: PubMed 9657469Suryapranata H, van 't Hof AW, Hoorntje JC, de Boer MJ, Zijlstra F. Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction. Circulation. 1998 Jun 30;97(25):2502-5. doi: 10.1161/01.cir.97.25.2502.
Background: PubMed 12176950Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 Aug 13;106(7):798-803. doi: 10.1161/01.cir.0000025585.63486.59.
Background: PubMed 15500897McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
Background: PubMed 17197707Brott BC, Anayiotos AS, Chapman GD, Anderson PG, Hillegass WB. Severe, diffuse coronary artery spasm after drug-eluting stent placement. J Invasive Cardiol. 2006 Dec;18(12):584-92.
Background: PubMed 18725485Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.
Background: PubMed 21251625Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.
Background: PubMed 19463469Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.
Background: PubMed 30898253Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
Background: PubMed 33091360Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.
Background: PubMed 32473887Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
Individual participant dataSharing planned: Yes. The data is available and can be requested, subject to approval, if a reasonable clinical research analysis plan is provided to the corresponding author.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jing Zhao, Dr contact

Yurun Su, Dr contact

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jing Zhao, Dr (+8618919062327, jzhao14@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late lumen loss at 9 months after index PCI (time frame: 9±2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06794801, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.